29 September 2026, Malmö, Sweden: PILA PHARMA AB (publ) (FN STO: PILA), a clinical stage biotech company pioneering development of an oral TRPV1-antagonist as a potential first-in-class treatment for obesity and diabetes, today announces it has initiated the clinical trial site that will conduct the Part 1 (safety) of PP-CT04 and the site has been given permission to enroll participants.
The site initiation and activation is the final step before the clinical site can enroll participants in the trial. It ensures that the principal investigator and trial staff have been trained in the trial protocol, that the regulatory and ethics documentation is in place, and that the site's procedures and facilities meet the requirements of the trial and GCP regulations.
PP-CT04 is a two-part, randomised, double-blind, placebo-controlled, parallel-group, 12‑week trial investigating the safety, tolerability, pharmacokinetics and efficacy of XEN-D0501 in obese participants.
The trial is designed to explore a within-subject dose titration approach to reach anticipated therapeutic plasma concentrations of XEN-D0501 not previously investigated.
Dose escalation will be carried out individually for each participant, beginning at 4 mg BID and increasing stepwise up to a maximum of 16 mg BID. Each dose level will be administered for 1 week, resulting in a maximum dose escalation period of 4 weeks. Once the highest tolerable dose has been reached and confirmed to be tolerable, the participant will continue treatment at that dose for an 8-week maintenance period.
PP-CT04 is divided into two parts with the same overall design, but Part 1, as a pilot safety cohort with 8 participants, entails more intense safety monitoring. It is enrolment for this Part 1 that will begin now in collaboration with Clinical Trial Consultants AB.
Part 2 may start once all participants in Part 1 have been dosed for at least 5 weeks and once a favourable recommendation has been given by the internal safety review committee.
Chief Scientific Officer and Founder, Dorte X. Gram comments:
“The initiation and activation of the clinical site are important milestones as it concludes weeks of formal preparation following the regulatory approval of the trial, whereby numerous documents for compliant trial execution are completed. The site initiation visit itself allows for the Sponsor, PILA, to meet the actual trial staff, share our story, and our vision for developing a TRPV1 antagonist as treatment of obesity and co-morbidities, a simple, accessible tablet solution with a differentiated safety profile, that could be a good fit to current market needs.”